Most medical device manufacturers utilize a classic water fall development process. This is a risk –averse, top down approach that does not keep pace with demands of today’s market place. We at AMDD are the first to develop a set of design and development processes that leverage modern rapid prototype techniques in circuit design and 3D printing and modern Requirement management tools to iterate elements of a medical device piece wise; creating all supporting documentation, requirements, risk elements, traces, test cases etc. that creates a single medical device work product. This creates iterations of products and product features that are tested, verified and validated allowing for tweaks, requirement changes, risk updates and compliance updates as needed.
THE AGILE DESIGN PROCESS
Principles behind the AgileMDD Manifesto
We follow these principles:
Our highest priority is to satisfy our partner through early and continuous delivery of work product..
Welcome changing requirements, even late in development. Agile processes harness change for our partner’s competitive advantage.
Deliver working prototypes frequently, from a couple of weeks to a couple of months, with a preference to the shorter timescale.
Business people and developers must work together daily throughout the project.
Build projects around motivated individuals. Give them the environment and support they need, and trust them to get the job done.
The most efficient and effective method of conveying information to and within a development team is face-to-face conversation.
Agile processes promote sustainable development. The sponsors, designers, developers, and users should be able to maintain a constant pace indefinitely.
Continuous attention to technical excellence and good design enhances agility.
Simplicity–the art of maximizing the amount of work not done–is essential.
The best architectures, requirements, and designs emerge from self-organizing teams.
At regular intervals, the team reflects on how to become more effective, then tunes and adjusts its behavior accordingly.